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First received: December 14, 2022

Clinical Trial: A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia

Study Status: Completed

Recruit Status: RECRUITING

Condition: Hemophilia

Study Type: INTERVENTIONAL


Official Title: A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ? 12 Years With Severe

Brief Summary: This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia.The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (?12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment.The total study duration will be up to approximately 50 months (200 weeks, 1 study month is…

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